Duns Number:030899271
Device Description: Ambulatory Infusion Pump
Catalog Number
Nimbus
Brand Name
Nimbus
Version/Model Number
Nimbus
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 23, 2016
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
b6d9b2b2-3208-4c08-8b3f-587f6d3eab7e
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
October 13, 2015
Package DI Number
10814371020041
Quantity per Package
24
Contains DI Package
00814371020044
Package Discontinue Date
September 23, 2016
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 19 |